Olympus Corporation of the Americas recalled 10,257 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall follows reports that some devices did not undergo thermoforming, risking deformation and loss of performance during medical procedures. This recall affects both domestic and international distribution, including 274 units in the U.S.
Devices which did not undergo thermoforming could deform and lose performance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The Single Use 3-Lumen Sphincterotome V is utilized in medical procedures for papillotomy. Healthcare providers use this device to assist in the removal of bile stones or to perform other therapeutic interventions.
The potential for deformation occurs when the devices do not undergo necessary thermoforming, which can compromise the structural integrity and performance of the device during critical medical procedures.
This recall is not part of a broader industry pattern.
The recall presents serious safety concerns for patients as the malfunction of these devices could lead to inadequate treatment during medical procedures.
The model number can typically be found on the device packaging or instruction manual.
Expect a refund or replacement processing time of 4 to 8 weeks once the returned device is received by Olympus.
Keep records of receipts, communication with Olympus, and any medical records related to the use of the device.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC411Q-0730. These devices are designed for use with an Olympus endoscope and guidewire for papillotomy. The devices were distributed worldwide, with 10,257 units recalled, including 274 in the U.S.
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